Metaplasticity in the Human Motor Cortex: Validation of an Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percent Change in MEP Amplitude
研究概览
简要总结
The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants.
详细描述
The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants. Our primary objective is to compare pre- and post-measures of cortical excitability before priming tDCS (anodal, cathodal or sham) [M1], directly after priming tDCS [M2], directly after inhibitory rTMS [M3], and 10 minutes after inhibitory rTMS [M4]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to compare pre- and post- measures of cortical excitability after inhibitory and excitatory priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to changes in cortical plasticity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will be blinded to treatment group, investigator administering tDCS will be blinded to which treatment arm subject is assigned to, and the data analyst will be conducting analysis off site and is different than investigator applying stimulation.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must be at least 18 years of age (all genders, races, ethnicity)
- •Must have no current psychiatric or neurologic issues
- •Must not have any conditions listed in
排除标准
- •Must be fluent in English
- •Exclusion Criteria:
- •History of major psychiatric illness
- •Actively using neuropsychoactive medication
- •Legal or mental incompetency
- •Substance use disorder, abuse or dependence, with active use within the last three months
- •Significant medical or neurological illness
- •Prior neurosurgical illness
- •Prior neurosurgical procedure
- •History of seizure
- •History of ECT or TMS treatment within the past there months
- •Presence of a pacemaker, implanted medical pump or device, metal plate, or metal object in skull or eye (including shunts, dental implants, facial tattoos with metallic ink)
- •Pregnant women
研究组 & 干预措施
Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS
Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.
干预措施: rTMS (Device)
Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS
Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.
干预措施: rTMS (Device)
Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS
Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.
干预措施: rTMS (Device)
结局指标
主要结局
Percent Change in MEP Amplitude
时间窗: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand
次要结局
- Cortical Silent Period(tDCS + rTMS assessed and reported pre and post (approximately 10 minutes))
- Simple Reaction Time(The final outcome will be percent change in the reaction time from pre- to post- intervention.)
研究者
Sarah Pirio Richardson
Assistant Professor of Neurology
University of New Mexico